This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01448525
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.

Condition or disease Intervention/treatment Phase
Hypotrichosis Drug: bimatoprost ophthalmic solution 0.03% Drug: bimatoprost vehicle solution Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
 Drug: bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Other Name: LATISSE®
Placebo Comparator: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
 Drug: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall [ Time Frame: Week 16 ]
    Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.


Secondary Outcome Measures :
  1. Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score [ Time Frame: Baseline, Week 16 ]
    The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have inadequate eyelashes
  • Never used prescription eyelash growth products

Exclusion Criteria:

  • No visible eyelashes
  • Permanent eyeliner or eyelash implants
  • Semi-permanent eyelash tint, dye, or extensions within 3 months
  • Over-the-counter eyelash growth products within 6 months
  • Any disease, infection or abnormality of the eye or area around the eye
  • Eye surgery within 3 months, or the anticipated need for eye surgery during the study
  • Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448525


Locations
Layout table for location information
United States, Florida
Coral Gables, Florida, United States
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Medical Director Allergan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01448525    
Other Study ID Numbers: GMA-LTS-11-002
First Posted: October 7, 2011    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
 Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents